MAUDE Adverse Event Report: MEDIVANCE, INC. ¿ 1725056 ARCTIC SUN STAT; ARCTIC SUN DEVICE

Catalog Number 60000000

Device Problems Insufficient Cooling (1130); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Event Description

It was reported that the patient had been rewarming since 11am yesterday, but arctic sun device had not been making warm water and patient was not reaching targeted temperature (tt).Patient temperature (pt) was 35.7c, targeted temperature (tt) was 34c, water temperature (wt) was 32c, water flow rate (wfr) was 2.4 l/m.Troubleshooting foley in place, no secondary temperature probe, but patient temperature (pt) was correlated on bedside monitor.Verified good pad coverage with no exposed abdomen.Event log shows 1am, 45 ac power lost and alarm 05 (water reservoir empty) times 3.Nurse confirmed device was unplugged and water was added.System diagnostics were outlet monitor temperature (t1) was 34.1c, outlet control temperature (t2) was 34.1c, inlet temperature (t3) was 32.4c, chiller temperature (t4) was 8.1c, water flow rate (wfr) was 2.4 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 58 percentage, mixing pump command (mpc) was 0, heater 100 percentage, water reservoir level (wrl) was 5, system hours were 1094.6, pump hours were 537.3.Explained when device lose power it recognized water lost because pads were not drained.When water was added and then water in pads began circulating at therapy restart, it caused an overfill which inhibited warm water circulation.Walked through stop therapy and drained 16 ounces water from device.Restarted therapy.Called back 20 minutes later and water temperature (wt) was 38c and increased.Advised to call back with any additional issues or concerns.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported that the patient had been rewarming since 11am yesterday, but arctic sun device had not been making warm water and patient was not reaching targeted temperature (tt).Patient temperature (pt) was 35.7c, targeted temperature (tt) was 34c, water temperature (wt) was 32c, water flow rate (wfr) was 2.4 l/m.Troubleshooting foley in place and no secondary temperature probe, but patient temperature (pt) was correlated on bedside monitor.Verified good pad coverage with no exposed abdomen.Event log shows 1am, alarm 45 (ac power lost) and alarm 05 (water reservoir empty) alerted 3 times.Nurse confirmed device was unplugged and water was added.System diagnostics showed that the outlet monitor temperature (t1) was 34.1c, outlet control temperature (t2) was 34.1c, inlet temperature (t3) was 32.4c, chiller temperature (t4) was 8.1c, water flow rate (wfr) was 2.4 l/m, inlet pressure (ip) was -7 psi, circulation pump command (cpc) was 58 percentage, mixing pump command (mpc) was 0, heater 100 percentage, water reservoir level (wrl) was 5, system hours were 1094.6 and pump hours were 537.3.Explained when device lose power, it recognized water lost because pads were not drained.When water was added and then water in pads began circulating the therapy restart, it caused an overfill which inhibited warm water circulation.Walked through stop therapy and drained 16 ounces water from device and then restarted therapy.Called back 20 minutes later and water temperature (wt) was 38c and increased.Advised to call back with any additional issues or concerns.

Manufacturer Narrative

Per investigator evaluation, bd has determined that this mdr event is not reportable.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

• Brand Name: ARCTIC SUN STAT
• Type of Device: ARCTIC SUN DEVICE
• Manufacturer (Section D): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer (Section G): MEDIVANCE, INC. ¿ 1725056; 321 s taylor ave; suite 200; louisville 80027
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17512035
• MDR Text Key: 321713793
• Report Number: 1018233-2023-06033
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 00801741161513
• UDI-Public: (01)00801741161513
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60000000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other